Kornimate/medical-research-clean huggingface dataset:
stress-relief management for treatment of late complications in type 2 diabetes

Conditions: Albuminuria; Diabetes Mellitus, Type 2; Diabetes Complications

Summary: the purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.

patients with type 2 diabetes and increased albumin excretion have an increased risk of renal failure and cardiovascular events. it has recently been shown, that psychosocial stress is an additional major risk factor contributing to the increased risk of cardiac events. however, it is not clear, whether a structured stress-relief training of patients reduces the risk of micro- and macrovascular damage in type 2 diabetes. comparisons: conventional treatment of diabetes according to national guidelines is compared to conventional treatment plus structured stress relief management training.

Eligibility criteria:
inclusion criteria: * diabetes type 2 * albuminuria * age 30-70 exclusion criteria: * diabetes duration \< 3 years * preexisting non-diabetic kidney * psychiatric disorders * alcohol or drug abuse * malignant tumors or hematologic disorders * heart failure nyha iii-iv * acute coronary syndrome

Keywords: diabetes type 2 late complications stress relief management psychosocial stress
effect of blood flow restricted aerobic exercise in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.

the aim of this study is to show, whether the effect of low-intensity aerobic exercise training combined with blood flow restriction is similar on both glycemic and cardiorespiratory status compared to moderate-intensity continuous aerobic exercise, in individuals with "type 2 diabetes mellitus" .

Eligibility criteria:
inclusion criteria: * having type 2 diabetes * not have been recruited any exercise programme for 6 months * volunteering to participate in the study exclusion criteria: * nephropathy * retinopathy * have had myocardial infarction at least 6 months ago * stable or unstable angina pectoris * the presence of peripheral artery disease * resting blood pressure above 160/100 mmhg * body mass index over 35 kg / m2 * history of deep vein thrombosis, pulmonary embolism or stroke

Keywords: blood flow restricted exercise type 2 diabetes aerobic exercise
brain machine interface (bmi) in subjects living with quadriplegia

Conditions: Spinal Cord Injury

Summary: in this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. subjects will undergo surgery to implant a unilateral subdural strip electrode (resume ii, model 3587a) over the motor cortex. these electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted activa pc+s. the cortical sensing data will be 1. either processed in the activa pc+s; or 2. off-loaded via the nexus d communication device (medtronic) to a computer.


Eligibility criteria:
inclusion criteria: * ais grades a \& b * level of injury c5 or c6 * local community dwelling * stable chronic injury * stable health status and upper extremities * completion of clinical protocol 01 exclusion criteria: * coagulopathy * anticoagulation * pregnancy
zero-fluoroscopic ablation versus conventional fluoroscopic ablation for the treatment of ventricular arrhythmias

Conditions: Ventricular Arrythmia; Ventricular Premature Complexes; Ventricular Tachycardia

Summary: this study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using ensite navx as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus ensite navx or plus carto as the imaging modality.

catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including carto and ensite navx, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. ensite navx system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. this study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using ensite navx as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus ensite navx or plus carto as the imaging modality.

Eligibility criteria:
inclusion criteria: * ventricular tachycardia * ventricular premature complexes exclusion criteria: * organic ventricular tachycardia or ventricular premature complexes * drug-induced ventricular tachycardia or ventricular premature complexes

Keywords: fluoroscopy ablation three dimensional ventricular arrhythmias radiation
effectiveness and costs of internet-based treatment for harmful alcohol use and face-to-face treatment in addiction care

Conditions: Alcohol Use Disorders

Summary: the purpose of this trial is to compare the effectiveness and costs of a five-module internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. the hypotheses to be tested through this trial are that: 1. the internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment. 2. the internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment. the design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. a minimum of 350 participants will be recruited and randomized into two groups: intervention group 1: all participants in this group will have access to the five-module internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (cbt) who assists and counsels the participant throughout the program. intervention group 2: all participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.


Eligibility criteria:
inclusion criteria: * 18 years or older * 16 points on alcohol use disorders identification test or at least 3 criteria on the international classification of diseases (icd-10) for alcohol dependence * resident in stockholm county exclusion criteria: * lack of understanding of the swedish language. * doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care. * doctor's assessment that there is a need for medication for alcohol dependence.
nitazoxanide therapy for patients with covid-19 pneumonia

Conditions: Covid19; Corona Virus Infection; Pneumonia, Viral

Summary: multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. population: 500 hospitalized patients with pneumonia derived from covid-19 (coronavirus disease-19), either confirmed by rt-pcr (real time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. control group: placebo 8/8 hours for 5 days.

sarita-1 is a multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide for hospitalized patients with pneumonia derived from covid-19 (coronavirus disease-19) experimental group: 250 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. control group: 250 patients received placebo 8/8 hours for 5 days. population: patients with clinical symptoms of covid-19: dyspnoea and/or fever and/or cough) and: either computed tomography scan suggestive of viral pneumonia or confirmatory molecular test by rt-pcr (real time polymerase chain reaction),

Eligibility criteria:
inclusion criteria: * patients requiring supplemental oxygen \[peripheral oxygen saturation (spo2) \< 93%\], admitted to hospital with covid-19 symptoms associated with chest computed tomography (ct) scan suggestive of viral pneumonia or positive nasopharyngeal swab test for sars-cov2 (rt-pcr) * age equal or superior to 18 years * non-pregnant women * willingness to receive study treatment * providing written and informed consent or the same consent signed by a family member exclusion criteria: * impossibility to use oral medications * history of severe liver disease (child pugh c class) * previous renal failure * severe heart failure (nyha 3 or 4) * copd (gold 3 and 4) * neoplasia in the last 5 years * known autoimmune disease * individuals with known hypersensitivity to study drug * previous treatment with the study medication during the last 30 days * clinical suspicion of tuberculosis and bacterial pneumonia

Keywords: covid19 coronavirus clinical trial placebo-controlled randomized brazil nitazoxanide hospitalized patients covid-19 sars-cov-2 new coronavirus multicenter double-blind
the association mechanism between the microbiome and the development of community pneumonia was studied based on the analysis of pulmonary microbiota - host interaction network

Conditions: Community Pneumonia

Summary: 1. the difference of lung flora between the healthy group and the cap group was compared, and the core flora involved in the development of cap was identified. 2. to predict the metabolites associated with cap. 3. identification of genes related to immune response in cap. 4. construct the pulmonary microbiota - host interaction network with metabolites as the link.


Eligibility criteria:
inclusion criteria: * according to the cap clinical diagnostic criteria in the guidelines for the diagnosis and treatment of community-acquired pneumonia in adults in china (2016 edition), cases eligible for community-acquired pneumonia were included and screened. exclusion criteria: * alveolar lavage fluid samples without electronic bronchoscopy were excluded for mngs etiological examination of the case.
study to assess in home use of evolocumab (amg 145) administration using either an automated mini-doser or a prefilled autoinjector/pen

Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemia

Summary: the primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (amd) or autoinjector/pen (ai/pen).


Eligibility criteria:
inclusion criteria: * fasting ldl-c at screening \> 85 mg/dl * fasting triglycerides less than or equal to 400 mg/dl (4.5 mmol/l) exclusion criteria: * new york heart association (nyha) iii or iv heart failure * uncontrolled cardiac arrhythmia * uncontrolled hypertension * type 1 diabetes or poorly controlled type 2 diabetes * uncontrolled hypothyroidism or hyperthyroidism

Keywords: ldl-c, triglycerides, high cholesterol
use of perioperative photograph as a motivation for increasing range of motion after primary total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: total knee arthroplasty (tka) is recognized as a successful procedure for treating osteoarthritis (oa) of the knee. one important factor that make the successful surgery is the degree of knee flexion. providing more range of motion after tka impact on the convenience of daily of life such as climbing stairs, sitting on the floor particularly in asian cultures which require a lot of ground activities. data are limited on the added benefits of perioperative photograph as motivation for increasing range of motion after tka. half of participants received perioperative photograph as motivation, while the other half did not after total knee arthroplasty.

all participants received spinal anesthesia, multimodal local anesthetic infiltration and patient controlled analgesia (pca) for 24 hours post surgery. the surgical techniques, postoperative medications and rehabilitation protocols were identical in both groups. perioperative knee range of motion (rom) were measured with long arm goniometer immediately after close the wound. perioperative knee photographs in full flexion and extension positions were taken and were given to experimental group in the day after surgery. postoperative knee rom were recorded at day 3, 6 week, 3 month and 6 month. the outcome assessors were blinded to treatment groups during the study period.

Eligibility criteria:
inclusion criteria: * primary oa of the knee, aged less than 80 years old, and able to understand and comply with the study procedures. exclusion criteria: * knee range of motion less than 90 degrees * psychotic disorders * history of stroke * inability to undergo a spinal block
evaluation of improved preparation time to a coverage in patients with acute wounds by use of vistacare® versus dressings

Conditions: Leg Injury

Summary: primary objective: demonstrate that in patients with acute leg wounds with skin defect, vistacare® accelerates the formation of a quality granulation tissue and reduces preparation time to a cover gesture. secondary objectives: * evaluate the success of hedging gesture * assess the quality of the bud by colorimetry * assess tolerance * collect medical and economic data on the care of patients included * evaluate the quality of life of patients * assess patient comfort * evaluate the ease of use for the caregiver


Eligibility criteria:
inclusion criteria: * man or woman * age from 18 to 65 inclusive * patient with acute or leg sores (s), traumatic, with skin defect with or without external fixators and without exposure to fine fabrics (functional tendon, artery, vessel, bone, osteosynthesis material ...). these wounds may be burns, deep second degree only. * patient having no associated pathology * patient has given its written consent, lighting, dated and signed * patient affiliated to a social security scheme * voluntary patient and able to comply with the protocol requirements * patient whose wound is located below the knee * patient whose wound date of less than 2 weeks * a patient whose wound has a minimum area of 10 cm2 * patient whose wound does not require surgical debridement after inclusion (if surgical debridement is necessary, it must be performed before inclusion in the study) exclusion criteria: * pregnant or breastfeeding women * women of childbearing potential not using effective contraception (combined hormonal, iud) and failing achieving a pregnancy test and getting the result before starting treatment * patients do not speak and do not read french * patient with one or more risk factors such as smoking more than 5 cigarettes a day, diabetes, autoimmune disease * patients with such treatment during or within one month prior to inclusion in the study: corticosteroids, topical corticosteroids at the immunosuppressive wound or radiotherapy * a patient whose wound is located at a place not compatible with the use of vistacare® * patient with traumatic wound leg with exposure to some tissues (functional tendon, artery, vessel, bone, osteosynthesis material ...) * patient with general signs of infection (temperature, lymphangitis, osteitis proven) * patient with a bleeding wound * patient with a burn to a stage other than deep second degree * patients with a wound whose area is less than 10 cm2 * patient with a plague of nontraumatic leg * previous participation in this trial * patient in exclusion period from another clinical trial or participated in a clinical trial in the month before inclusion * patient whose wound is more than 2 weeks * patient whose wound was treated by hyperbaric chamber
intervention to reduce safety behaviors

Conditions: Social Anxiety

Summary: social anxiety is associated with significant deficits in social and occupational functioning. the proposed study seeks to evaluate the feasibility of implementing a brief text-based intervention for decreasing social anxiety related safety behaviors among veterans attempting to re-integrate into the workforce. findings from this pilot will support a larger randomized controlled study examining the efficacy of the intervention for improving functional outcomes and quality of life among veterans.


Eligibility criteria:
inclusion criteria: * active enrollment in compensated work therapy * score of \> 25 on the social phobia inventory * score of \> 47 on the subtle avoidance frequency examination exclusion criteria: * concurrent enrollment in another study related to social anxiety or improving functional status * recent (\<3 month) history of psychiatric hospitalization, detoxification admission, or suicide attempt

Keywords: veteran social anxiety workforce
impact de la marge de résection sur la survie à long terme et le taux de récidive des patients atteints de cancers colorectaux opérés au chus entre 2006 et 2016 pour des métastases hépatiques

Conditions: Colorectal Cancer Stage IV

Summary: we retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery.

main objective : evaluation the margin status (\ 10mm) on the survival and recurrence in colo-rectal liver metastases surgery. secondary objectives include : evaluate potentiel effects of neo-adjuvant chemotherapy, portal embolisation, and evaluate potentiel bias such as size and number of liver metastases, tnm status of original tumor, timing between primary and metastasis, and extra-hepatic disease. methods : a retrospective cohort study is built where all patients undergoing liver surgery for colorectal liver metastases between 2011 and 2015 are analysed. subjects are separated in groups according to their margin status. the local and distal recurrence rates are measured and well as survival. data is obtained through our hospital data management system. inclusion criterias include age over 18, primary colorectal cancer metastatic to the liver, having undergone surgery between 2011 and 2015, available pathology reports with required data, available radiologic follow-up. exclusion criterias include repeat liver resection, documented grossly positive margins (r2 resection), and unavailable pathologic information and follow-up. using survival as primary outcome (kaplan meier) and considering 25% potential loss to follow-up, we calculated a sample size. since this a retrospective study, no patient is directly contacted. data will is handled by the surgery resident responsible for the project as well as by research assistants. statistical analysis are performed accordingly.

Eligibility criteria:
inclusion criteria: * primary colorectal cancer with liver metastasis * undergone liver surgery at our center between 2011 and 2015 * pathological reports with margin status available (or specimen still available for measurement) exclusion criteria: * repeat liver resection no tissu or incomplete pathological information

Keywords: liver surgery colorectal liver metastasis
micro-hematology analyzer for viral/bacterial description

Conditions: Infection Viral; Infection, Bacterial

Summary: the purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, thecytotracker, to measure complete blood count (cbc) parameters and discriminate between viral and bacterial infections.

the purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, the cytotracker, to measure complete blood count (cbc) parameters. the cytotracker results will be compared to those from a standard benchtop analyzer (horiba point of care hematology analyzer, abx micros es 60). if successful, the data from this study would be used to support a pre-submission meeting to the fda for the cytotracker. in addition to validating the cytotracker, the project will study the use of cbc parameters to distinguish between observed bacterial or viral infections in adults. hospitalized adult subjects with suspected or confirmed viral or bacterial infections will be enrolled in the study. after enrollment a venous blood sample (baseline sample) will be collected and the cytotracker will be used to measure cbc parameters (cell counts and population distribution). clinical data will be abstracted from the medical record and used with the cbc parameters to develop an algorithm to distinguish between bacterial and viral infections.

Eligibility criteria:
inclusion criteria: -covid positive or suspected/confirmed bacterial infection (lower uti, pneumonia, septecemia, etc). -adults 18 years of age and older. -meet sirs criteria anytime during the ed presentation. exclusion criteria: * subjects who are unable to give informed consent will be excluded * subjects with the following conditions will also be excluded: known white blood cell, neutrophil, and lymphocyte disorders active cancer patients; for solid tumors, subject will be excluded if he/she has received chemotherapy in the last 3 months. * subjects who are pregnant
safety and efficacy outcomes following previously administered short-term treatment with shp607 in extremely premature infants

Conditions: Retinopathy of Prematurity (ROP); Intraventricular Hemorrhage; Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity

Summary: the purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to shp607, as compared to a standard neonatal care group.

in this long-term follow-up study, participants who enrolled in shp607-202 (nct03253263) will be followed from 12 months corrected age (ca) through 60 months ca. participants will not receive any investigational product in this study.

Eligibility criteria:
inclusion criteria: * participants who were randomized into study shp607-202 (nct03253263). participants who were randomized, but did not complete study shp607-202 (nct03253263) must be at least 12 months ca. * written informed consents (and assents, if applicable) must be signed and dated by the participant's parent(s)/legally authorized representative(s) prior to any study-related procedures. the informed consent and any assents for underage parents must be approved by the institutional review board (irb)/independent ethics committee (iec). exclusion criteria: - participants are excluded from the study if the participant or participant's parent(s)/legally authorized representative(s) is/are unable to comply with the protocol or is/are unlikely to be available for long-term follow-up as determined by the investigator.